Post-Operative Thoracolumosacral Orthosis for PJK

NCT06491030 | Recruiting Phase 4 DMC FDA Device

• 1 other identifier: 2023-2446
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 6

Brief Summary

Proximal junctional kyphosis (PJK) is a common post-operative radiographic finding after surgery for adult spinal deformity (ASD) patients. Although the clinical relevance of isolated PJK is unclear, PJK can progress to symptomatic proximal junctional failures which requires a large revision surgery. Currently, post-operative bracing with a thoracolumbosacral orthosis (TLSO) is common practice after spinal deformity surgery, however the efficacy of this in preventing PJK is unknown. This multi-center randomized control trial identified 84 patients undergoing thoracolumbosacral fusion for ASD and plans to study the efficacy of a novel post-operative TLSO in preventing the development of PJK as defined by the proximal junctional angle on 6-month post-operative X-rays.

Conditions

Proximal Junctional Kyphosis; Adult Spinal Deformity Surgery; Thoracolumbosacral Orthosis

Outcome Measures

Primary Outcomes (1)

• The incidence of proximal junctional kyphosis development

  As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values.

  This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.

Secondary Outcomes (2)

• Change in patient reported outcome measures

  6 week and 6-month time points

• Change in patient reported outcome measures

  6 week and 6-month time points

Study Arms (2)

Thoracolumosacral Orthosis

EXPERIMENTAL

Patients randomized to this arm will be fitted with an Aspen Medical Products "Align PJK™" TLSO brace. This is a 3-point, rigid hyperextension TLSO brace which is currently FDA approved under a 510k exemption but not commercially available. With this brace, the sternal pad height/width and belt component will be adjusted to optimize patient position and comfort. The brace will also be fitted with an external temperature sensing probe. Patients will be instructed to wear the brace at all times, including when in bed for 6-weeks post-operatively. At the 6-week visit patients will be asked to self-report compliance with the brace

Device: Align PJK™ TLSO brace

No brace

PLACEBO COMPARATOR

Patients in the control arm will be treated without a brace but will have no other differences in their post-operative treatment protocol. This will be considered "usual care" for the purposes of this study.

Other: Standard of Care

Interventions

Align PJK™ TLSO brace DEVICE

Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively.

Thoracolumosacral Orthosis

Standard of Care OTHER

Patients will receive the standard of care postoperative instructions without a brace

No brace

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years-old
• Undergoing primary thoracolumbosacral fusion for ASD with an upper instrumented vertebrae (UIV) between T8-L2 and lower instrumented vertebrae (LIV) of S1 or the ilium.

You may not qualify if:

• Osteoporosis (defined as a T-score \<-2.5 at the time of surgery)
• Body mass index (BMI) \>35 kg/m2
• Revision fusions
• Fusions for trauma
• Those with a neuromuscular etiology for their deformity (i.e. Parkinson's disease, cerebral palsy, post-stroke, etc.)
• An underlying inflammatory arthropathy

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Aspen Medical Products: collaborator

Study Sites (6)

Indiana Spine Group

Carmel, Indiana, 46032, United States

ACTIVE NOT RECRUITING

University of Kansas

Overland Park, Kansas, 66211, United States

ACTIVE NOT RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

University of Texas Health, Houston

Bellaire, Texas, 77401, United States

ACTIVE NOT RECRUITING

Texas Back Institute

Dallas, Texas, 75243, United States

ACTIVE NOT RECRUITING

Virgina Mason Franciscan Health

Seattle, Washington, 98101, United States

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 8, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-01

Locations

US (6)